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EC number: 203-812-5
CAS number: 110-88-3
Genetic toxicity in vitro:
No bacteriotoxicity and no mutagenicity was observed in an Ames
test with TA1535, 1537, 98, 100 (BASF AG, 1988). This standard plate and
preincubation test was performed according to the current OECD-guideline
471 with test concentrations up to 5000 µg/plate, lacking the E. coli or
TA 102 strains (detection of oxidizing or cross-linking mutagens).
Trioxane was also negative in a chromosomal aberration test in
V79 Chinese Hamster Cells (in vitro cytogenicity study in mammalian
cells, Hoechst AG, 1992), and in a HGPRT assay with V79 cells (in vitro
gene mutation study in mammalian cells, Hoechst AG, 1992). Both assays
were performed according to the current OECD-guidelines (473 or 476)
with and without metabolic activation.
No contradictory results were reported in further Ames assays
(e.g. Kowalski et al., 1984; Zeiger et al., 1988) which were not
performed according to current guidelines. Though, in a Mouse Lymphoma
Assay (Celanese, 1980) an increase of mutation frequencies
was observed in presence of S-9 mix. This effect was clearly related to
an increase in cytotoxicity at concentrations far beyond the limit
concentration. Due to this high level of cytotoxicity the dose
dependency could not be clarified. No increase in mutation frequencies
was observed in absence of S-9 mix.
Genetic toxicity in vivo:
Trioxane caused no increase in unscheduled DNA synthesis in an in vivo UDS assay.
The assay was performed according to OECD Guideline 486 and male
rats were gavaged with dose levels up to 2000 mg/kg bw (BASF AG, 1997).
In an intraperitoneal Mouse Micronucleus Test trioxane did not
induce an increase in micronucleated polychromatic erythrocytes
(Pryzyboljewska et al., 1984). The assay was performed according to OECD
Guideline 474 with test concentrations up to 4250 mg/kg bw.
Summarized sufficient and reliable evidence was found in in
vitro and in vivo assays, to proof that no classification for
genotoxicity is warranted.
No classification for genetic toxicity indicated according to Directive
67/548/EEC and Directive 1272/2008.
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